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Background: Clinical research studies are important for the developmentof new treatments in healthcare. The quality of clinical research relies on the competence, skills, and knowledge of the research team. Clinical research nurses (CRNs) are important members of clinical research teams as they are responsible for various tasks specified in study procedures. Internationally, nurses have been engaged as CRNs in in many areas of medicine, such as oncological research, for several decades. However, there is a lack of consensus concerning their professional role and a clear work description is lacking. In Sweden, nurses are becoming increasingly involved in research as CRNs, yet the CRN role is undefined as there is no Swedish national competence description that could guide CRNs’ work tasks, requirements for education, and management of ethical issues. Furthermore, the processof becoming a CRN is not understood. Increasing international research into the CRN role has shown that the role differs between countries.There is a lack of Swedish studies, including studies of the process of transitioning from being a registered nurse (RN) to a CRN. Since consensus is lacking concerning the CRN role in Sweden, we need to explore it further and examine how nursing perspectives are influencing it. The overall aim of this thesis was therefore to explore the professional role of CRNs in Sweden and the transition of RNs to being CRNs.

Methods: Both quantitative (studies I and II) and qualitative (studies III and IV) methods were used. The analyses are based on data from questionnaires and individual interviews of CRNs in Sweden. In study I, descriptive statistics and test–retest analyses were used to analyze the validity and reliability of the translated CTNQ-SWE. In study II, descriptive statistics and one-way ANOVA were used to analyze reported work tasks, perceptions, and differences between groups of CRNs. In studies III and IV, qualitative content analysis according to Graneheimet al., (2004) was used to analyze the transition, i.e., becoming and being a CRN.

Results: CRNs perform new and diverse work tasks and are often involved throughout the study process, with the greatest activity in data management and the actual conducting and evaluation of clinical studies (e.g., scheduling and performing procedures and tests according to the research protocols). There is seldom any work description or competence framework to guide nurses through the transition to the CRN role, placing them in an uncertain position where they must struggle to adaptiv to their new role and work tasks. To perform these new work activities, CRNs need more support as well as education in research procedures, regulations, and ethics. During the transition, CRNs improve their knowledge of research, regulations, and ethics and increase their experience of clinical research practice and collaboration in networks. They also learn and develop from dealing with challenging situations, such as the informed consent process. Furthermore, problem solving, study requirements, and ethical reasoning are emphasized as challenging. When passing through the different phases of transition to the CRN role, the nurses achieve expanded competence, change didentity, and growing confidence as informal leaders. CRNs also advocate for patient rights and mentor others involved in research, but they simultaneously lack acknowledgement and a formal leadership role.

Conclusions and clinical implications: This thesis provides important insights into the CRN role in Sweden. It highlights the transition of RNs to becoming CRNs as well as their experiences of working as and becoming CRNs. The thesis reports that CRNs, overall, seem to be satisfied with their work, but some of their experiences highlight that skills, education, and organizational structures require improvement; forexample, appropriate introduction and support are required during the transition to the CRN role. Ethical challenges call for ongoing discussion in research teams. One conclusion is that CRNs’ competences and tasks need to be clarified. Developing clear competence pathways for nurses to become CRNs, including mentorship and support, could be one way of acknowledging CRNs’ important work, thereby creating a better outlook for high-quality clinical research procedures. Making the CRN professional title more homogeneous nationally and internationally would make comparisons easier. This would clarify CRNs’ work tasks and role in Sweden and extend the nursing perspective on ethics. This thesis adds to a slowly growing body of literature on the CRN role and is relevant to both practitioners and policymakers. Additionally, it illustrates a need to develop both educational and mentoring support aswell as career pathways for RNs to become CRNs, which could improve the quality of clinical research in Sweden.